MAUDE Adverse Event Report: LUMENIS LTD MOSES PULSE; POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-0008700
Medical Device Problem Codes	Defective Device (2588); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this report is one of two complaints that pertain to the same event (mfr.Report # 2124215-2025-26425).
Event or Problem Description
It was reported that during a procedure, a fiber was connected to the console, and cracking and sparking noises came from the console.The console prompted error code 162 (laser deck-spare blast shield), so the burned debris shield was replaced.The procedure was not completed due to this event.This occurrence happened in two different procedures.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.This event is for the second aborted/procedure console.
Additional Manufacturer Narrative
Note: this report is one of two complaints that pertain to the same event (mfr.Report # 2124215-2025-26426 and mfr.Report # 2124215-2025-26425).The console was not returned for analysis; however, a field service engineer (fse) serviced the system at the customer's facility.Upon initial service, the system was inspected and found that the blast shields and focus lens were blown, and the energy power was low due to the damaged focus lens and blast shields.The focus lens was cleaned, the brick was realigned, and the system was verified.However, the checklist failed due to low power.Another service was performed in which the fiber focus assembly and blast shields were replaced.Brick 2 cavity alignment was performed, and near and far alignment was carried out for all bricks.The system was tested and found to be okay.Although spare blast shields were not recognized, the functionality was unaffected, and the users were advised.Another work order was performed, including unpacking and installing the system in the urology theatre.The top white cap of the display base was found damaged, and brick 3 hr optic was marked, so it was replaced and aligned.Brick 4 cavity alignment was performed, and the system was successfully tested after repairs.The issue was resolved by replacing the high reflective mirror, focus lens assembly, and blast shield, and the unit was within specification.As a result, the console was functioning as intended.The damaged component was likely causing the abnormal sound that was reported.The malfunction found could have affected the device performance leading to the event experienced by the customer.
Event or Problem Description
It was reported that during a procedure a fiber was connected to the console and cracking and sparking noises came from the console.The console prompted error code 162 (laser deck-spare blast shield), so the burned debris shield was replaced.The procedure was not completed due to this event.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.This event is for the second aborted/procedure console.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21916047
• Report Number: 2124215-2025-26425
• Device Sequence Number: 21088142
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)190812(10)32
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GA-0008700
• Device Catalogue Number: GA-0008700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 04/27/2025
• Supplement Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 08/12/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown